FDA批准默克的PD-L1单抗联合阿西替尼,用于治疗晚期肾细胞癌

2019-05-15 不详 MedSci原创

美国食品和药物管理局(FDA)已批准Merck的PD-L1单抗Bavencio(avelumab)联合Inlyta(阿西替尼),用于晚期肾细胞癌RCC患者的一线治疗。

美国食品和药物管理局(FDA)已批准Merck的PD-L1单抗Bavencio(avelumab)联合Inlyta(阿西替尼),用于晚期肾细胞癌RCC患者的一线治疗。

该决定基于III期JAVELIN Renal 101研究(NCT02684006)的阳性结果,其中该组合与舒尼替尼相比显着提高了中位无进展生存期(PFS)超过5个月。该研究包括不论PD-L1表达和IMDC(国际转移性肾细胞癌数据库)预后风险组的患者。

Merck表示他们感到"特权",他们可以为"患有晚期肾细胞癌的患者提供一种新的治疗选择,"该公司总裁Rehan Verjee说。

RCC是一种癌症,其中PD-L1表达可能有助于抑制抗肿瘤的免疫应答。

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    2019-05-17 smartjoy
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    2019-05-15 医者仁心5538

    学习了

    0

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欧洲药品管理局(EMA)已经验证了Merck的PD-L1单抗Bavencio(avelumab)治疗晚期肾细胞癌(RCC)患者的疗效。该次验证是基于关键的III期JAVELIN肾脏101试验的结果。

NICE推荐将罗氏的PD-L1单抗Tecentriq,用于治疗转移性非小细胞肺癌

杉醇联合,用于针对表皮生长因子受体(EGFR)或间变性淋巴瘤激酶(ALK)的靶向治疗失败、PD-L1肿瘤比例评分在0%-49%的转移性非小细胞肺癌(NSCLC)患者。

Maxinovel的口服PD-L1抑制剂被证明与PD-L1单抗Durvalumab有相似活性

Maxinovel Pharmaceuticals是一家专注于开发免疫肿瘤治疗和靶向治疗药物的生物技术公司。它利用其口服免疫肿瘤产品平台,为全球患者提供多组分有效组合的单个口服避孕药片剂。

欧盟监管机构批准罗氏的组合疗法(Tecentriq、阿瓦斯汀和化疗药)用于一线治疗肺癌

罗氏周五宣布,欧盟委员会授权PD-L1单抗Tecentriq(atezolizumab)联合阿瓦斯汀(bevacizumab)和化疗药,用于转移性非鳞状非小细胞肺癌成人患者的一线治疗。该药物的获批是基于其三期IMpower150的试验数据。

罗氏的AKT抑制剂ipatasertib联合PD-L1单抗和紫杉醇,显示出对三阴性乳腺癌的治疗前景

罗氏公布了一项Ib期临床试验结果,结果显示无论PD-L1的表达量有多少,AKT抑制剂ipatasertib与PD-L1单抗atezolizumab和Taxol(紫杉醇)联合治疗三阴性乳腺癌(TNBC),总体反应率达73%。在该研究的26名受试者中,19名对该药物组合应答。

罗氏的PD-L1单抗Tecentriq 治疗三阴性乳腺癌即将获得FDA批准

罗氏的PD-L1单抗Tecentriq(atezolizumab)与化疗药(Abraxane,nab-paclitaxel)联合,用于PD-L1阳性的、无法切除的局部晚期或转移性三阴性乳腺癌(TNBC)患者,通过了FDA的批准测试。